Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases

Completed

• Conditions: Periodontal Diseases
• Interventions: Biological: biofluids

• Registration Number: NCT04407026
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.

Detailed Description

A total of one hundred participants were enrolled for the study. All individuals were assessed clinically and radiographically. Full-mouth clinical periodontal examinations were performed by the measurements of probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements were recorded at six sites around each tooth with a manual periodontal probe. The participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-04-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Last Update Submitted: 2020-05-25
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Systemically healthy individuals
• No history of smoking
• Individuals between the ages of 25-50 years
• Having at least 20 natural teeth

Exclusion Criteria

• Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer)
• A history of smoking
• Pregnancy or lactation
• A history of surgical/non-surgical periodontal therapy in the past 1 year
• Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 3 periodontitis	biofluids	Stage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss.
Healthy	biofluids	Healthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP\<10% and no sign of clinical attachment loss and radiographic alveolar bone destruction.
Gingivitis	biofluids	Gingivitis group (n=25) had PD≤3 mm with BOP\>50% in the entire mouth, and no clinical attachment loss or alveolar bone loss.

Primary Outcome Measures

Name	Time	Method
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels	one day after the clinical periodontal measurements	Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.

Trial Locations

Locations (1)

Zeynep Pinar Keles Yucel; 🇹🇷 Giresun, Turkey